While through a series of discussions with

While discussing the barriers associated, I went through a series of discussions with internal organization of Diabetic boot co. and with other stake holders includes insurance firms and GTAI.

The diabetic boot company official’s claims multiple challenges while discussion on German market and certain conditional questions are generated in this chapter.

·         “How to sell the device?”  

·         “Who going to pay for the product?”

·         “Which is going to be a better market entry mode?”

·         “How much clinical support evidence will they demand?”

·         “Does it fit into an existing reimbursement code?”

·         “Is there a political dimension?”

·         “Regardless of clinical outcomes, what will the payers think of our product?”

·         “How long it will take?”

In my interview with GTAI (German trade and invest) organization, they specifically outlined challenges which innovative health care companies from outside faces. Ms. Julia Pietsch (Manager- Healthcare GTAI) brings to notice that the main concern on medical device companies from abroad is on regulatory affairs. To initialize any kind of operations in Germany they need to register the company as either branch of foreign company or as Gmbh (Gesellschaft mit beschränkter Haftung) along with notary attestation.


While having an interview with Dr. Ivo simundic (FRESENIUS) an industry leader in healthcare, he got multiple experience on working with regulatory affairs and he clearly states if documents are not fully covered and the pilot studies or validation studies are having not clear authenticity can lead to failure of entering in reimbursement code system. Which is really a matter of time and money. He states for a new technology it will take minimum three to five years to get the reimbursement code, while for an existing technology or existing code it may get into system within six months. Dr. Ivo also mentioned

“German health care system is designed in a way where people are fully insured and they don’t pay for any treatments and consultations. Companies without coverage of statutory health insurance contract can only go through a very least market potential. They can sell via private insurers but the market share is very low. In Germany, Patients won’t spend money for any medical device or patient care device from their pocket. The option remain for these companies to get into contract with GKV association where they will get hillfmittel number for reimbursement. ”

From the interviews the main challenge diabetic boot co. facing is about time.  Each money spending on this market is valuable as time. Diabetic boot co. already having CE certification and FDA approval by 2015 and they started selling in UK market and US market. On this second phase they are investing money on new big markets and one among is Germany. Medical industry market is very much characterized by slowness due to heavy regulated processes. These regulations can results in slow product lifecycle, low rate of technology change, and slow market growth.